The Site Activation Partner is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Pfizer standards. Responsibility span within a country or multi-country depending on the geographical region and business needs.

ROLE RESPONSIBILITIES
Clinical Trial Site Activation

Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for sites initiationProvide support to resolve issues or concerns and timely escalation of Site issues where applicablePrepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572 for internal regulatory approval within the required timelinesManage and coordinate with other supporting roles to ensure timely site activation and operational activities.Take the Lead, initiate and coordinates activities related to the compilation of high-quality IRB/EC package and ensure timely submission to approval (Central and or Local and in countries where applicable), and other committees as per country requirementsCollaborate with in-country regulatory groups, and provide related/applicable site documents, as well as in countries where parallel submissions (Regulatory authority and ethics) are requiredCoordinate the timely communication, documentation and responses between Pfizer and Central Ethics committee to bring clinical study to approval (country dependent)Support investigators sites with local IRB workflow from preparation, and submission through approvalLead or assist with the preparation, handling, and distribution of clinical documentation and reports according to the scope of work and standard operating procedures.Support & implement activities in Shared Investigator Platform to align with Pfizer strategy as it relates to the role

Clinical Trials ConductPost site activation, initiate and coordinate activities and essential documents management with the investigator’s sites towards the compilation of a high-quality documents and updates through the life cycle of a study such as the documents management for protocol amendments, FDA 1572, Ethics Committee annual approvals and other activities required during study conductEnsure continuation of IRB/Ethic’s and other committees activities Post SIV, and related submission, notifications, reapprovals etc..Responsible for timely filing of documents to Trial Master File and assisting with periodic quality review of study files for accuracy and completenessAccurately update and maintain clinical trial systems that track site compliance and performance within project timelinesSupports investigator sites, and study teams in preparation for and providing responses to site audits / inspections

Internal & External CommunicationMaintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requestsProvide functional updates on a country and site level as requiredEstablish tools for efficient updates to study team as needed regarding site status, issues, delays, approvalsDisseminate Central or Local Ethics Approval to study team and Investigator Sites where applicableCommunicate Local sites approvals to study team members and stakeholders

Clinical Trial Site Support

As needed, perform awareness sessions on Pfizer requirements with site personnel to ensure ongoing compliance with study documentation in accordance with prevailing laws, Good Clinical Practices, and Pfizer standardsIdentify and resolve investigator site issues within required timeframes; align with study team and local country colleagues on corrective and preventative actions to close open issues and to prevent recurrence / persistence of issuesAdditional Responsibilities:Deep understanding of the Site Activation requirements and processes within the country and be able to develop and implement in more than one (1) country to enable multi-country coverage.Assigned as Site Activation Partner Point of Contact (PoC) on a study conducted in multi-country:Represent the SAP role on the studyTake the lead in the compilation and preparation of the Investigator Initiation Package (IIP) Template for the study and share with SAP team globallyCommunicate with SAPs globally on study information and timelinesBe an SME on one or more system and/or process, be the go-to person and train the SAPs on these respective systems or processesRepresent the SAP role on global initiativesAble to act as an SME on projects and initiatives, as requestedMentor for new hires on processes, systems and SAP activities facilitating and optimizing the time from hire/training to assignment on a studyAble to manage a high volume of, complex studies and sites

Systems & Tools

Ability to use and learn systems, and to use independentlyEthics, National Networks and Governing Bodies Portals and platformsElectronic Investigator Site File (e.g. Florence)Microsoft SuiteClinical Trial Management Systems (CTMS)Electronic Trial Master FileDocument exchange portalsShared Investigator Platform

QUALIFICATIONS / SKILLS

BASIC QUALIFICATIONS

School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor’s degree in life sciences preferredMinimum 4 years relevant experience in Clinical Trials environment and clinical site activation. Experience working in the pharmaceutical industry/or CRO is an assetDemonstrated deep knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulationsMust be fluent in Local language and in English.Multilingual capability is an assetFor individuals based in Canada: Bilingualism (French, English) is an assetEffective verbal and written communication skills relating to colleagues and associates both inside and outside of the organizationGood technical skills and ability to learn and use multiple systemsExperience working in a global environmentExperience in working in more than 1 country is an assetExperience in leading or participating as an active member of cross functional teams, task forces, or local

PHYSICAL/MENTAL REQUIREMENTS

Demonstrated knowledge and understanding of key operational elements of a clinical trial and processes (e.g., study start-up, conduct, close-out activities, reporting, etc.) and ability to gain command of these processesUnderstand the quality expectations and emphasis on right first time. Demonstrate compliance with all applicable company, regulatory and country requirements. Attention to detail evident in a disciplined approachProven ability to work independently and also as a team memberAbility to organize tasks, time and priorities, ability to multi-taskUnderstand basic medical terminology, GCP requirements and proficient in computer operations
 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Flexible and adapt to off working hours in a global environment (when applicable)

Work Location Assignment: Remote

 
Work Location Assignment: Remote

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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